Quality Assurance and Regulatory Support
The Clinical Research Specialist (CRS) provides support for IRB applications, renewals and amendments, regulatory document preparation and submission, adverse event reporting, research data coding, research subject safety, department scientific review, auditing, and monitoring.
All departmental research must be submitted to the CRS. The Principal Investigator (PI) must provide a study protocol or design, and a consent form. The CRS facilitates the scientific review process for new research requiring peer review and will assist with the development of the consent form and other documents required by the Human Subjects Protection Office (HRPO) for IRB review. The CRS will ensure all departmental and divisional approvals are secured as required for IRB related activities such as submissions, amendments, renewals, and study closure.
Scientific review involves the analysis and evaluation of scientific merit for proposed research including feasibility and applicability of study aims, by a panel of peers. This is a departmental requirement for any new research that has not already undergone a scientific review process. Studies funded by granting agencies or multi-center studies that conduct scientific review will be exempt from this requirement. Reviewers are assigned by the Director of DoCTR, and will provide the PI with written feedback. The PI will have the opportunity to submit a rebuttal if warranted, amending the protocol when indicated. Once accepted, the PI will receive an approval letter. The CRS is responsible for obtaining signatures from the Director of DoCTR and Department Chairman prior to submission of new research to Washington University’s Human Research Protection Office (HRPO) for IRB review.
The CRS serves as a regulatory resource for the DoCTR pool, ensuring educational requirements and certifications are maintained and assisting with the development and implementation of new policies and procedures related to clinical research.
Clinical Research Specialist